NIH SBIR/STTR PROGRAM. Yvonne Duglas-Tabor Cancer Immunology & Hematology Division of Cancer Biology

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1 NIH SBIR/STTR PROGRAM Yvonne Duglas-Tabor Cancer Immunology & Hematology Division of Cancer Biology

2 SBIR / STTR Program Mission Supporting scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy one small business at a time.

3 Program Descriptions and Goals Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. 2.5% Stimulate technological innovation Meet Federal R&D needs Foster and encourage participation by minorities and disadvantaged persons in technological innovation Increase private-sector commercialization of innovations derived from Federal R&D Small Business Innovation Development Act of 1982

4 Program Descriptions and Goals Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 0.30% Stimulate and foster scientific and technological innovation through cooperative research Foster technology transfer between small business concerns and research institutions Small Business Research and Development Enhancement Act of 1992

5 SBIR / STTR Participating Agencies TOTAL ~ $2.0 + B FY 2004 DOD HHS NASA DOE NSF DHS USDA DOC ED EPA DOT HUD SBIR/STTR SBIR/STTR SBIR/STTR SBIR/STTR SBIR/STTR SBIR SBIR SBIR SBIR SBIR SBIR New New

6 SBIR/STTR: 3-Phase Program PHASE I Feasibility Study $100K and 6-month (SBIR) PHASE II or 12-month (STTR) Award Full Research/R&D $750K and 2-year Award PHASE III (SBIR/STTR) Commercialization Stage Use of non-sbir/sttr Funds

7 SBIR PROGRAM ELIGIBILITY CHECKPOINTS Organized for- profit U.S. business At least 51% U.S.- owned by individuals and independently operated Small Business located in the U.S. 500 or fewer employees P.I. s primary employment with small business during project

8 Applicant is Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business STTR PROGRAM ELIGIBILITY CHECKPOINTS Minimum 30% by U.S. research institution U.S. Research Institution College or University; other non-profit research organization; Federal R&D center Intellectual Property Agreement Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization

9 SBIR / STTR ELIGIBILITY OWNERSHIP AND CONTROL have questions? Contact the SBA Size Specialists Request an eligibility determination

10 SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS

11 SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] *DISCUSS WITH AGENCIES

12 STTR RESEARCH INSTITUTION PARTNER Non-profit organization owned and operated exclusively for scientific or educational purposes Non-profit medical and surgical hospitals eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques

13 STTR RESEARCH INSTITUTION PARTNER Formal collaborative relationship with SBC Perform minimum of 30% of the research/r&d (maximum 60%)

14 PI Eligibility on STTR Formal collaborative relationship: PI at RI establishes contract between RI and SBC describing PI s involvement PI is NOT required to be employed by SBC Minimum 10% effort PI and co-investigator must be paid at either SBC or RI, but NOT BOTH PI s signature on Face Page is agreement to conforming to Solicitation requirements

15 FEE/PROFIT Up to 7% of total direct and F&A costs may be requested for fee Must be REQUESTED/JUSTIFIED in application Does not need to be negotiated Only SBC eligible; no contracts, consortium or other third party are eligible for fee Not direct or indirect cost

16 PERFORMANCE of RESEARCH ACTIVITIES All research/r&d must be performed in its entirety in the U.S. Rare cases to conduct testing of specific patient populations outside U.S. is allowable Travel to scientific meeting in foreign country allowable Foreign consultants/collaborators allowable, but must perform consulting in U.S.

17 Important Facts to Remember Eligibility is determined at time of award No appendices allowed in Phase I The PI is not required to have a Ph.D. or M.D. The PI is required to have expertise to oversee project scientifically and technically Applications may be submitted to different agencies for similar work Awards may not be accepted from different agencies for duplicative projects

18 NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.

19 AN ADDED DIMENSION TO THE NIH CULTURE The National Institutes of Health needs to work much more closely with industry to find cures for disease and improve global health and will aggressively seek out partnerships with private companies. -- Dr. Elias Zerhouni NIH Director

20 National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Largest SBIR/STTR set-asides

21 National Institutes of Health Use SBIR/STTR Help NIH Use SBIR/STTR Help NIH Office of the Director Meet Its Mission Conduct innovative R/R&D that results in product, process, or service that will... Improve human health Speed process of discovery Reduce cost of medical care/ cost of research Improve research tools

22 NIH SBIR/STTR Program What s New? Register in NIH Commons: See Website Type 2 Competing Continuation Ph II Awards Clarification of Instructions for Preparing Human Subjects Section of Research Plan Sample SBIR Applications FDA Resources and Useful Websites Technical Assistance Programs EO 13329: Encouraging Innovation in Manufacturing

23 NIH SBIR/STTR Program Reminders Similar, Essentially Identical or Identical Applications to NIH awarding components (ICs) NOT allowed Submission Dates: Postmark Date acceptable for applications submitted in response to PHS Commercialization Plan: ALL Phase II Details in PHS SBIR/STTR Grant Solicitation

24 Budget and Award Amount 2004 Budget NIH ****Propose CDC a Realistic ~8.1M and Appropriate FDABudget for ~0.8M the Research**** N/A AHRQ Phase I Phase II SBIR $563.3M $630.9 ~2.0M $100K* 6 months* $750K* 2 years* STTR $67.6M $100K* 1 year* $750K* 2 years*

25 Types of SBIR / STTR Awards ~95% ~4-5% <1% GRANTS: you decide the research and product to be designed or developed (SBIR / STTR) CONTRACTS: The government decides the research and general product to fill their perceived need (SBIR only) COOPERATIVE AGREEMENTS: Similar to grants, but awarding IC has substantial involvement in carrying out the project's activities.

26 SOLICITATION RECEIPT DATES SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: January Receipt: Apr 1, Aug 1, Dec 1 Contract Solicitation Release: August Receipt: November (~2nd Friday) NIH Guide Release: Weekly Receipt : Dates as noted

27 Our ideas.(examples) Biodefense NIH SBIR/STTR RESEARCH GRANT TOPICS Biosilicon devices Biosensors Nanotechnologies Bioinformatics Behavioral research Computational Biology Telehealth Biocompatible materials Acousto-optics /opto-electronics Imaging technologies Genetically engineered proteins Proteomics / Genomics Complementary and Alternative Medicine

28 Your ideas... NIH SBIR/STTR RESEARCH GRANT TOPICS Investigator-initiated R&D Research topics related to the NIH mission Other areas of research within the mission of an awarding component

29 DOES MY TECHNOLOGY FIT IN NIH? See Mission Statement! Solution to Real Problem. that affects Real People!

30 NIH Guide for Grants & Contracts Special SBIR/STTR Opportunities Go Beyond the SBIR/STTR Omnibus Solicitation.

31 NIH GUIDE: PAs and RFAs SBIR/STTR Opportunities

32 SBIR/STTR : Tip of the R&D Iceberg SBIR/STTR --Joe Henebury DOT Prog. Mgr 2.8% Other Research Opportunities NIH Budget SBIR STTR NIH Extramural Research Budget

33 NIH Roadmap

34 NIH Roadmap General Objective: Make the NIH optimallyeffective in meeting its mission of improving health and quality of life. Impact: Planned focus areas for next 10 years $ 128 M in 2004 to >$ 2 B in 2009 Translating Discoveries into Practice

35 Specific Objectives Accelerate the pace of discoveries in the life sciences. Rapidly translate discoveries into practice. Build an integrated system that is far more effective than current approaches. Multi-disciplinary and multi-organizational collaborations aimed at improving human health

36 NIH Roadmap Focus Areas Molecular Imaging Nano-biomedicine Biomaterials Computational Biology/Informatics Structural Biology Building Blocks, Networks, Pathways Inter-Disciplinary Research Public/Private Partnerships Research Communities Research Networks High-Risk Research

37 Roadmap Funding Opportunities Request for Applications (RFAs) High Throughput Molecular Screening Assay Development Meetings and Networks for Methodological Development in Interdisciplinary Research Training for a New Interdisciplinary Research Workforce Supplements for Methodological Innovations in the Behavioral and Social Sciences Dynamic Assessment of Patient-Reported Chronic Disease Outcomes Interdisciplinary Health Research Training: Behavior, Environment and Biology Short Programs for Interdisciplinary Research Training

38 What does the Roadmap mean? Maximum Provides funding opportunities associated with new initiatives Minimum Indicates planned focus areas at NIH for the next ten years Team science is emphasized but it s not all there is.

39 Grant Application Process

40 NIH SBIR/STTR PROGRAM Application Process for Research Grant Small Business Concern Applicant Initiates Research Idea or Identifies PA/RFA Contact NIH Staff Review Solicitation Discuss: Project IC Relevance Budget NIH Center for Scientific Review Assign to IC and IRG Submit SBIR/STTR Grant Application to NIH

41 Grant Application Assignment: What if I cannot determine which IC is most appropriate?

42 Application Assignments Institutes/Centers NIH Center for Scientific Review RECEIPT and REFERRAL STAFF refer applications to Institute or Center as the potential funding component: Match between research proposed and IC s mission Multiple IC assignments when technologies cross-cut more than one IC Scientific Review Groups NIH Center for Scientific Review RECEIPT and REFERRAL STAFF refer applications to an Initial Review Group and Study Section: -- Match between research and scientific review group within IRG -- Scientific expertise/specialization -- Special Emphasis Panels Ad hoc; Not Chartered

43 Applications Submitted to NIH Center for Scientific Review REGARDLESS OF INSTITUTE/CENTER TOPIC LINKAGE Cover Letter: A Valuable Tool Suggest potential awarding component(s) Discuss areas of expertise appropriate for the application s review Indicate individual(s) or organization(s) in conflict

44 Small Business Concern NIH SBIR/STTR PROGRAM Review Process for Research Grant Submits SBIR/STTR Grant Application to NIH NIH Center for Scientific Review Assign to IC and IRG Applicant Initiates Research Idea ~2-3 months after submission Scientific Review Groups Evaluate Scientific Merit ~2-3 months after review Advisory Council or Board Recommend approval Grantee Conducts Research IC Allocates Funds IC Staff Prepare funding Plan for IC Director

45 Peer Review of SBIR/STTR Grant Applications

46 Streamlined Procedures of NIH Grant Application Review Reviewers Rate applications: upper half and lower half Discuss at review applications identified between 100 and 300 Triage / UNscore applications between generally Applicants: ALL Automatically receive essentially verbatim written critiques (Summary Statement)

47 NIH REVIEW CRITERIA (Phase I) Significance (Real Problem/Real People) Approach (Research Design, Feasible) Innovation (New or Improved?) Investigators (PI and team) Environment (Facilities/Resources) Protection of Human Subjects Animal Welfare Budget

48 HINT! Research Plan should include answers to questions described under Review Criteria! (See Solicitation)

49 NIH REVIEW CRITERIA (Phase II) Demonstrated Feasibility in Phase I Commercialization Plan High Degree of Commercial Potential based on Commercialization Plan Protection of Human Subjects Animal Welfare Budget

50 Phase II Commercialization Plan Included in ALL Phase II applications. Detailed instructions provided. Value of the SBIR/STTR Project, Expected Outcomes, and Impact Company Description Market, Customer, and Competition Intellectual Property (IP) Protection Finance Plan Production and Marketing Plan Revenue Stream

51 Post Review: Next Steps Read the summary statement Re-read the summary Statement Contact your Program Director Guidance and advice Discuss options

52 Common Problems with Applications Inadequately defined test of feasibility Diffuse, superficial, or unfocused research plan Lack of sufficient experimental detail Questionable reasoning in experimental approach Uncritical approach Failure to consider potential pitfalls and alternatives Lack of innovation Unconvincing case for commercial potential or societal impact Lack of experience with essential methodologies Unfamiliar with relevant published work Unrealistically large amount of work proposed

53 NIH Allows Amended Applications Two amended applications allowed Generally half of the reviewers are new Request for change of reviewers must be supported An opportunity to revise and improve your application

54 NIH REVIEW CRITERIA (Amended Applications) Responses to comments from the previous review Appropriateness of improvements in the revised application

55 NIH SBIR/STTR APPLICATION PROCESS TIMELINE 2-tiered review process SBIR/STTR Scientific/Technical Adv Council Est.Award Receipt Dates Peer Review Board Review Date Apr 1 June/July Sept/Oct Dec Aug 1 Oct/Nov Jan/Feb Mar Dec 1 Feb/March May/June July ~7 9 months 90-Day pre-award costs are allowable: At your own risk..

56 NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2003 Success Rate (%) % % 43% % 5 28% $563 M SBIR/STTR (set aside $556M) Phase I Phase II 15 22% Fast-Track SBIR STTR

57 NIH SBIR/STTR AWARD PROCESS Congratulations! The check is in the mail (almost)

58 NIH SBIR/STTR AWARD PROCESS Avoid Delays Human Subject Issues (OHRP) IRB and Assurances Animal Welfare Issues (OLAW) IACUC (Animal Involvement) EIN (Entity Identification Number) DUNS Number Third Party Involvement Contracts, Consortia, Consultants

59 Gap Funding Options Phase I Phase II

60 NIH SBIR/STTR Program Gap Funding Options Phase I / Phase II Fast Track Simultaneous submission / concurrent review No-Cost Extension (Ph I or Ph II) Extension in time with no additional funds Administrative / Competitive Supplements Discuss with Program Director Phase II Competing Continuation Maximum of $1M/yr for 3 years Response to IC-specific PA New!

61 NIH SBIR/STTR FAST-TRACK Bridging the Funding Gap Phase I + Phase II (Simultaneous submission and Concurrent review) 7-9 months Phase I 6 month award (SBIR) 12 month award (STTR) Phase II 2 year award Funding Gap Reduced/Eliminated Phase I Completed: Submit satisfactory Phase I Final Report Discuss Fast-Track option with Program Director

62 NIH SBIR FAST-TRACK Best Option For Everyone? No!! Convincing preliminary data? Clear, measurable, achievable milestones? Well-conceived Commercialization Plan? Letters of Phase III support/interest? Track record for commercializing?

63 Transitioning to the Marketplace

64 Lab to Life Mt. FDA???????

65 Commercialization: A Magic Formula? Phase I + Phase II = Phase III Typical for SBIR/STTR Projects that do not require clinical evaluation Phase I + Phase II Phase III Typical for SBIR/STTR Projects that require clinical evaluation and FDA approval

66 Commercialization Issues Phase II to Phase III: Pier or Mountain? Clinical evaluation and FDA approvals cgmp and GLP Facilities Partnerships and Strategic Alliances Drugs and Biologics require vast amounts of time and $$$ Average of 8.5 years (lab research/animal testing to clinical trials) Average of $1.6M

67 In NIH ovative Solutions to Commercialization Issues Competing Continuation Phase II Award From the Test Tube to the Medicine Cabinet

68 Competing Continuation Phase II Award Purpose - To take existing, promising compounds developed under a Phase II through the next step of drug discovery and development. Provide additional Phase II research support to continue assessing and improving devices or conducting preclinical studies of drugs or devices that ultimately require: clinical evaluation approval of a Federal regulatory agency refinements to durable medical equipment (DME) designs

69 Competing Continuation Phase II Award Eligibility SBIR Phase II awardee: Promising pharmacologic agents or devices have already been identified (or developed) and some preclinical pharmacology has been conducted. Response to an NIH Program Announcement Generally, $750k-$1M/year for up to 3 years Contact your Program Director to discuss!

70 Competing Continuation Phase II Award NIMH NICHD NCI NIAAA Participating ICs Also see PHS SBIR/STTR Grant Solicitation

71 Competing Continuation Phase II Award NHLBI NIAID NINDS NIDCD NIA Participating ICs

72 SBIR / STTR Toolbox Information and Resources

73 INFORMATION and RESOURCES A GOOD STARTING POINT NIH SBIR / STTR Grant Solicitation, Forms and Instructions Contacts at NIH National SBIR / STTR Resource Center

74 INFORMATION and RESOURCES HOW TO WRITE A GRANT APPLICATION Grant Application Preparation

75 INFORMATION and RESOURCES FINDING A PARTNER CRISP Award Database NIH Collaboration Opportunities and Research Partnerships NIH Office of Technology Transfer ott.od.nih.gov/

76 (cont) INFORMATION and RESOURCES FINDING A PARTNER Federal Laboratory Consortium for Technology Transfer State SBIR/STTR Support grants1.nih.gov/grants/funding/sbirsttr_resources.htm#st ate

77 INFORMATION and RESOURCES Updates Commercialization Plan Detailed Instructions CORP -- Collaborations / Partnerships Success Stories SBIR Phase II Competing Continuation Awards Sample Applications Data Sharing Plan (>$500K d.c. / year) files/not-od html

78 Updates (cont.) Success Stories Post Your SBIR / STTR Commercialization Success Stories! Recognition and visibility Leverage SBIR / STTR funds

79 Reminder Invention Reporting Grantees must report inventions Interagency Edison

80 INFORMATION and RESOURCES Tissue Banks and Repositories NCI Research Resources resresources.nci.nih.gov/ NIAID Reference Reagent Repository NIDA Drug Discovery / Drug Development

81 FDA Technical Assistance Each Component of FDA has an Office to Provide Technical Assistance to Manufacturers: Human Drug Products Biological Products Animal Drugs and Devices Food Products and Cosmetics

82 Key to the NIH Application, Review, and Award Process Communication

83 Visit the NIH Small Business Funding Opportunities Website

84

85 Contact NIH Staff Program Staff : Pre- Application Assess the fit What s New: PAs/RFAs Assist in finding collaborators Review Issues: Dos and Don ts Define product and focus application Application Review Award

86 Contact NIH Staff Program Staff : Post Review Discuss outcome of peer review Review Summary Statement What the rating means (numeric vs. **) Strengths and weaknesses Likelihood of funding Next steps If at first you don t succeed. Revise and resubmit Application Review Award

87 Contact NIH Staff Review Staff Scientific Review Administrator. Point of contact during review process Recruitment/Assignment of Reviewers Concerns about I/C Assignment or Review Review

88 Contact NIH Staff Grants Management Staff Pre-Award Steps Post-Award Advice Guidance Award

89 Top 10 Reasons to Seek SBIR / STTR Funding Opportunities 10. $2.0 Billion available 9. NOT A LOAN - no repayment 8. Provides recognition, verification and visibility 7. Potential leveraging tool to attract venture capital/other sources of $$$

90 Top 10 Reasons to Seek SBIR / STTR Funding Opportunities 6. Fosters partnerships (e.g., large corporations, academia) 5. Stimulates local and state economies = stronger national economy 4. Provides seed money to fund high risk projects

91 Top 10 Reasons to Seek SBIR / STTR Funding Opportunities 3. Intellectual property rights are normally retained by the small business 2. Small business concerns are recognized as a unique national resource of technological innovation

92 Top 10 Reasons to Seek SBIR / STTR Funding Opportunities 1. To make economic and societal contributions to America NIH + Army

93 Real Solutions.. Real Problems. Real People Seeing is Believing

94 Corneal Surgery with Femtosecond Lasers Dr. Ronald Kurz and Dr. Tibor Juhasz Intralase Corporation (CA) National Eye Institute SBIR: EY012340, EY014301

95 Entrepreneurial Audacity Discovery of Penicillin. First step on the moon Invention of the personal computer And now the first

96 Implantable Replacement Heart Dr. Robert Kung Abiomed Corporation (MA) National Heart, Lung, and Blood Institute HV AbioCor TM

97 Artificial Skin Drs. Naughton, Bartel, Riley, Hollister and Ratner Advanced Tissue Sciences, Inc., U.Michigan and U. Wash. National Institute of Neurological Disorders and Stroke SBIR: AR 40121, AR 41110, CA , DK041968, BRP: HL064387, DE Post-Burn Day 1 Post-Burn Day 21

98 Technology Entrepreneurship Intellectual Rigor + Hard Work + Passion + Mission

99 Real Solutions.. Real Problems. Real People Today s Ideas Lab to Life Tomorrow s Discoveries

100 Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: Fax: or Kay Etzler NIH SBIR/STTR Program Phone:

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